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ELLENCE SDV 200MG 100ML(表柔比星冻干粉注射剂)
药店国别  
产地国家 美国 
处 方 药: 是 
所属类别 2毫克/毫升,200毫克/100毫升 100毫升/瓶 
包装规格 2毫克/毫升,200毫克/100毫升 100毫升/瓶 
计价单位: 瓶 
生产厂家中文参考译名:
Hospira
生产厂家英文名:
Hospira
该药品相关信息网址1:
http://www.drugs.com/ellence.html
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
ELLENCE-SDV 2mg/ml 200mg/100ml sdv 100ml
原产地英文药品名:
EPIRUBICIN
中文参考商品译名:
艾伦斯-2毫克/毫升,200毫克/100毫升 100毫升瓶
中文参考药品译名:
盐酸表柔比星
曾用名:
简介:

 

部份中文表柔比星处方资料(仅供参考)
药品英文名
Epirubicin
药品别名
表阿霉素、法码新、盐酸表阿霉素、表柔比星、Pharmorubicin、4-Epi-Doxorubicin、4-Epi-Adriamycin、4-Epi-Dx、4-Epi-ADM、EADM、EPI
药物剂型
注射剂(粉):100mg,50mg。
药理作用
其主要作用机制是直接嵌入DNA的碱基对之内,干扰转录过程,阻止mRNA的形成而发挥抗肿瘤作用,EPI能抑制DNA和RNA的合成,故对细胞周期各阶段均有作用,为细胞周期非特异性药物。EPI对细胞膜和连转系统都有作用,但最主要的作用部位是细胞核。EPI在心脏细胞中的浓度低于ADM,对家兔的心脏毒性仅为ADM的1/4。
药动学
本品体内代谢与ADM相近,但有一些特点:
1.在带瘤动物中给药后1、24、48h,EPI在心脏、脾脏的浓度及48h在肾脏的浓度低于ADM。
2.血浆半衰期为30h,而ADM为43h。血浆廓清率本品每分钟为1400mg,而ADM每分钟为8801ml。因此,本品体内代谢、排出均较阿霉素快。本品与ADM一样主要经胆道排泄,48h尿中排出10%,4天内胆道排出40%。其中绝大部分以原形及与葡萄糖醛酸的结合物排出。这种结合发生在EPI氨基糖苷的第4′位置上的OH基,而在ADM则未发现这种结合,这可能是本品排出较快、药动学不同及急性毒性较低的部分原因。EPI不能透过血-脑脊液屏障。肾功能正常与否对本品的药动学影响不大。但由于主要由肝胆系统排出,对肝转移和肝功受损的患者,本品在血浆中的浓度维持时间较长,故应减低剂量。
适应证
与ADM相近。
1.恶性淋巴瘤、乳腺癌、小细胞肺癌、原发性肝癌、鼻咽癌和食管癌。
2.软组织肉瘤、肾细胞癌、胰腺癌。
3.肺腺癌、直肠癌、头颈癌。
禁忌证
1.对表柔比星、其他蒽环霉素或蒽类过敏者;
2.中性粒细胞计数小于1.5×109/L者;
3.带状疱疹等病毒感染性疾病患者;
4.既往使用过足量蒽环类抗生素,如柔红霉素或阿霉素(总剂量大于或等于400~500mg/m2)者;
5.周围血象白细胞低于3.5×10/L或血小板低于50×10/L者;
6.发热或严重感染者;
7.恶病质者;
8.水、电解质或酸碱平衡紊乱者;
9.胃肠道梗阻者;
10.严重心肌功能不全或近期有心肌梗死者;
11.严重肝功能不全者;
12.肾功能不全者。
注意事项
1.65以上老人及2岁以下幼儿慎用。
2.药物对妊娠的影响:美国药物和食品管理局(FDA)将本药妊娠分类为D类,其活性成分表柔比星能透过胎盘。所以在妊娠初期的3个月内禁用本药。
3.药物对哺乳的影响:哺乳期妇女不宜应用。
4.药物对老人的影响:老年患者应将总累积量减至400~450mg/m2。
5.用药前后及用药时应当检查或监测:用药前需全面测定心脏功能,除监测心电图外,有条件时可加做超声心动图和血清磷酸肌酸激酶活力测定、左心室喷射指数(LVEF)和PEP/LVEF比值等检查。每次用药前一定要随访心电图。每7~10天检查周围血象一次,每1~2月随访肝功能一次。同时要监测肝肾功能。
6.本药可能与柔红霉素和阿霉素呈交叉耐药性。
7.同时进行胸部放疗时,本药必须减量。
8.口服本药无效。可经由动脉、静脉推注或滴注,也可浆膜腔内或膀胱内给药,但不能用作鞘内注射。由于本药的肝清除量较高,肝动脉给药后,其血浆清除率比静脉给药高,所以本药更适合于局部给药如肝埃及插管给药或腹腔内给药。埃及插管给药、腹腔内给药或膀胱灌注给药,其全身作用微弱,因此心肌损害、脱发、骨髓抑制和胃肠道反应均明显低于全身给药。近来有人主张本药可用持续滴注给药法,以增强疗效且减少不良反应。
9.使用本药时应避光。
10.本药最好在输液后由侧管推入,同时避免药物外渗或漏至皮下。
11.用药期间应多饮水,用药前可给予5-HT3受体拮抗剂如昂丹司琼、凯特瑞、托烷司琼及甲氧氯普胺、地塞米松等药物,以预防恶心、呕吐等胃肠道反应。
12.与其他化疗药同用,应避免相互接触或放入同一容器内给药。
13.不能与肝素溶液混合,否则可形成沉淀。也不能长期与大麦性溶液接触。
14.不宜与地塞米松或琥珀酸氢化可的松同时滴注。
15.氨茶碱与本药接触可使溶液变成紫蓝色。
16.与头孢菌素类药物置于同一容器中可引致沉淀。
17.国外资料提示,本药用后1~2天可出现红色尿液。
18.国外资料提示,既往用过蒽环类抗癌药如阿霉素、柔红霉素者等应根据所用剂量而减量或不用本药。
19.国外资料认为,在最初出现左室功能障碍时应该停止本药治疗。
20.药物外渗时,国外资料提示处理方法为:于外渗区域使用氢化可的松局部皮下浸润,然后局部外用倍他米松/庆大霉素软膏,并使用弹性绷带(开始2天每12小时更换1次,然后每24小时更换1次,直到愈合)。
不良反应
不良反应较ADM轻,其防治可参考ADM。
1.骨髓抑制:表现为白细胞和血小板减少,属剂量限制性毒性。也可有血红蛋白的下降。
2.极少患者出现心脏毒性、绞痛样胸痛、轻度心电图异常变化,重者出现充血性心力衰竭。总剂量低于1000mg/m2时未发现急性心力衰竭。
3.轻度胃肠反应:恶心、呕吐、腹泻、胃黏膜炎。
4.局部可产生静脉炎,甚至蜂窝织炎和坏死。
5.可发生脱发、皮炎、色素沉着。
用法用量
静脉注射:1.75~90mg/m2,3周1次。2.40~50mg/m2,连续2天,3周后重复。3.60~90mg/m2,3周1次,每两个周期递增15mg/m2,达90mg/m2时不宜再增加。
药物相应作用
1.与环磷酰胺、氟尿嘧啶、甲氨蝶呤、顺铂等可发生协同抗癌作用。但与环磷酰胺、氟尿嘧啶、亚硝脲类、丝裂霉素合用时,可能引起严重的骨髓抑制,合用时应酌减剂量。
2.最好避免同时应用任何可能导致心脏损害的药物(包括含这类抗癌化疗药物),以避免加重心肌损害。3.给药期间,同用大剂量维生素C、维生素E或辅酶Q10有可能减轻表柔比星的心脏毒性,并有保护肝脏的作用。
4.使用本药时同时接种活疫苗,可能增加活疫苗感染的风险,故应谨慎。
专家点评
对恶性淋巴瘤、乳腺癌、小细胞肺癌、肝癌、鼻咽癌和食管癌疗效较好。对软组织肉瘤、肾癌、胰腺癌有一定疗效。对少数ADM治疗无效的肿瘤,如肺腺癌、直肠癌、头颈癌也可试用。EPI是阿霉素(ADM)的一个新衍生物,为ADM的同分异构体,它与ADM结构上的差异仅仅是ADM氨基糖部分4′位上的羟基由顺式变成了反式,但这种立体结构上的微小变化,却使其心脏和骨髓方面的毒性作用明显下降。

http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=11468
Ellence
Generic Name: epirubicin (EP i ROO bi sin)
Brand Names: Ellence
What is Ellence?
Ellence (epirubicin) is a cancer medication that interferes with the growth and spread of cancer cells in the body.
Ellence is used to treat breast cancer.
Ellence may also be used for purposes not listed in this medication guide.
Important information
You should not use this medication if you have an untreated or uncontrolled infection, severe liver disease, severe heart problems, or if you have recently had a heart attack.
Ellence may cause dangerous effects on your heart. Call your doctor at once if you have chest pain, shortness of breath (even with mild exertion), swelling, or rapid weight gain.
Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when Ellence is injected. Call your doctor if you have irritation or skin changes where the injection was given.
Ellence can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches).
Using Ellence may increase your risk of other types of cancer, such as leukemia.
Before receiving Ellence
Before you are treated with Ellence, tell your doctor about all other cancer medications and treatments you have received, including radiation.
You should not use Ellence if you are allergic to epirubicin or similar medications (Cerubidine, Adriamycin, Idamycin, Novantrone), or if you have:
•an untreated or uncontrolled infection (including mouth sores);
•severe liver disease;
•severe heart problems; or
•if you have recently had a heart attack.
To make sure Ellence is safe for you, tell your doctor if you have:
•liver or kidney disease;
•bone marrow suppression;
•heart disease; or
•if you have been treated before with doxorubicin, daunorubicin, epirubicin, idarubicin, or mitoxantrone.
Using Ellence may increase your risk of developing other types of cancer, such as leukemia. Talk with your doctor about your specific risk.
FDA pregnancy category D. Do not use Ellence if you are pregnant. It could harm the unborn baby. Tell your doctor if you become pregnant during treatment.
See also: Pregnancy and breastfeeding warnings (in more detail)
Use birth control to prevent pregnancy while you are receiving this medicine, whether you are a man or a woman. Ellence use by either parent may cause birth defects.
It is not known whether epirubicin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using Ellence.
How is Ellence given?
Ellence is injected into a vein through an IV. A healthcare provider will give you this injection.
Ellence is usually given together with other cancer medications. You may be given other medications to prevent nausea, vomiting, or infections.
Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when Ellence is injected.
If any of this medication accidentally gets on your skin, wash it thoroughly with soap and warm water.
Ellence can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Ellence injection.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid?
Epirubicin can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.
Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.
Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.
Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.
Do not receive a "live" vaccine while using Ellence, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
Ellence side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Ellence: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Tell your caregivers at once if you have:
•feeling short of breath, even with mild exertion;
•swelling, rapid weight gain (especially in your face and midsection);
•irritation or skin changes where the injection was given;
•nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
•fast, slow, or uneven heartbeats;
•anxiety, sweating, severe shortness of breath, wheezing, gasping for breath;
•chest pain, sudden cough, cough with foamy mucus, rapid breathing, coughing up blood;
•lower back pain, blood in your urine, little or no urinating;
•numbness or tingly feeling around your mouth, weak pulse, overactive reflexes, confusion, fainting;
•muscle weakness, tightness, or contraction;
•fever, chills, body aches, flu symptoms, sores in your mouth and throat; or
•pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin.
Common Ellence side effects may include:
•hot flashes, missed menstrual periods;
•temporary hair loss;
•feeling weak or tired;
•mild nausea, diarrhea; or
•eye redness, puffy eyelids.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect Ellence?
Many drugs can interact with Ellence. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Ellence, especially:
•acetaminophen (Tylenol);
•auranofin or gold injections to treat arthritis;
•cimetidine;
•rosiglitazone;
•an antibiotic or antifungal medication;
•an antidepressant--amitriptyline, doxepin, clomipramine, desipramine, imipramine, nortriptyline;
•birth control pills or hormone replacement therapy;
•cholesterol medications--atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin;
•heart or blood pressure medicine--amlodipine, atenolol, carvedilol, digoxin, diltiazem, enalapril, labetalol, lisinopril, methyldopa, nifedipine, verapamil, and others;
•HIV/AIDS medications;
•NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others;
•other cancer medications, especially docetaxel or paclitaxel; or
•seizure medications--carbamazepine, divalproex, phenobarbital, phenytoin, valproic acid, and others.
This list is not complete and many other drugs can interact with Ellence. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you. 

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